A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure

Completed · Not applicable

Conditions studied: Congestive Heart Failure, Diastolic Heart Failure, Systolic Heart Failure

In brief

This study will randomize participants with a diagnosis of congestive heart failure and at least one risk factor for hospitalization to either a tablet computer and web based disease management program or a telephone based disease management program. Both interventions are home based with heart failure education and symptom monitoring provided by nurse managers. The nurse managers are in close communication with both the participants and the participants' physicians . The components of the disease management program have been developed at Tufts Medical Center and the New England Quality Care Alliance with studies showing improved clinical outcomes, including reduced hospitalizations. The goal of this study is to transition this successful home monitoring and disease management program to a tablet computer and web-based implementation to both improve clinical outcomes (reducing hospitalizations and improving self-perceived health status) and improve provider-patient satisfaction. We hypothesize that the tablet computer based disease management will decrease heart failure hospitalizations.

Key facts

Study ID

NCT02084992

Run by

Tufts Medical Center

People needed

212

Starts

2014-06-01

Expected to finish

2019-09-01

Last updated by the study team

2019-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients age ≥ 18 with a primary care provider or specialist that is participating within the Collaborative Health ACO.
• Patient able to consent
• A diagnosis of heart failure with at least one of the following risk factors:
• Hospitalization for heart failure within the prior year
• NYHA class III-IV symptoms
• Most recent BNP ≥ 300 pg/mL (or Nt-proBNP ≥ 600 pg/mL) as long as within 90 days prior to enrollment

You may not qualify if…

• Acute myocardial infarction, PCI or CABG within 30 days before enrollment
• Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
• Illness other than heart failure deemed the principal limitation to life expectancy or principal cause of disability
• Severe angina as the principal cause of limitation
• Uncorrected valvular disease, except where valvular regurgitation was considered to be secondary to severe left ventricular dilation, or where surgical correction is deemed excessively risky or declined by the patient.
• Moderate to severe dementia such that unable to participate in disease management program
• Severe visual or auditory disability such that unable to participate in disease management program
• Hospice care
• Listed for heart transplantation
• No access to a working telephone
• Homeless or no stable home environment
• Not speaking a language in which the educational documents have been translated

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States
• MetroWest Medical Center — Framingham, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.